A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

Epilepsy Clinical Trial

— SPASMES-NIRS  

Official title:

A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899832
• Other study ID #: PI2012_843_0029
• Status: Recruiting
• Start date: February 21, 2013
• Est. completion date: February 2020

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice WALLOIS, MD, PhD
• Phone: +33 3 22 08 77 77
• Email: wallois.fabrice[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

Exclusion Criteria:

• Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• NIRS
Near Infra Red Spectroscopy

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Fondation Ophtalmologique Rothshild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in HbO	hemodynamic changes in [HbO] before spasms, during spasms, and after spasms	Day 0
Primary	changes in Hbr	hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms	Day 0